Needle array device

ABSTRACT

Methods of actuating a needle array device can include causing fluid to move through flow channels to needle apertures that are spaced apart from an inflow aperture at different distances where flow channels that have approximately equal pathway lengths and where the fluid can reach tips of the needle apertures approximately simultaneously, which can provide an approximately equal dosage or fluid volume through the tips of the needle apertures.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. application Ser. No.17/001,553, filed Aug. 24, 2020, which is a continuation of U.S.application Ser. No. 15/934,904, filed on Mar. 23, 2018, which issued asU.S. Pat. No. 10,751,484, which claims the benefit of and priority torelated U.S. Provisional Patent Application No. 62/450,921, filed onJan. 26, 2017, the disclosure of each of which is incorporated herein byreference in its entirety.

BACKGROUND Field of the Inventions

The present disclosure generally relates to mechanisms for injection anddosing, and more specifically, to devices for providing even and/orsimultaneous dosage of a fluid, such as a dermal filler, to a targetsite.

Description of the Related Art

Aesthetic dermal filler procedures have become increasing popular inrecent years, as they have proven to be quite effective in improving theappearance of the face, for example, in reducing the signs of aging bysmoothing wrinkles and folds, such as the nasolabial folds, and plumpingthe midface. Some of the more popular dermal fillers are soft, colorlessgel compositions made of hyaluronic acid. Hyaluronic acid (HA) is a longchain polymer, more specifically, a polysaccharide, which occursnaturally in body tissues. When chemically crosslinked, hyaluronic acidmakes an excellent, long lasting, dermal filler material. Dermal fillerprocedures are quite minimally invasive, and the results are nearlyimmediate. Further, hyaluronic acid naturally degrades in the bodytissues, and thus the fillers are temporary, for example, lastingseveral months to a year or more. Further, results of hyaluronic acidbased dermal filler procedures can be reversed using hyaluronidase.

Conventional dermal filler procedures are generally performed byinjection of the composition into or below the skin using a standardsyringe and a fine gauge needle. A typical dermal filler patient mayundergo from about 5 to about 10 injections in a single procedure, withinjection points across various regions of the face, neck, décolletage,hands, or other such areas. While the goal may be to improve theappearance of the entire face, a skilled aesthetic physician generallyaims to correct one or more specific regions of the face, for example,regions that lack volume such as the lips or the cheeks, or regions thatpresent specific wrinkles, such as deep nasolabial folds, with specificinput from the patient regarding areas he or she finds detracting to hisor her appearance. Injections are typically for volumetric improvement,sculpting, and/or wrinkle filling. These corrective areas typicallyrepresent specific regions (i.e., lips, brow, radial cheek lines, etc.).

SUMMARY

As noted, HA gel can be used as well to improve overall skin quality ofa large surface area, such as the entire face, neck décolletage, handsor other such areas via typical needle injection. To improve skinquality of these surface areas, anywhere from tens to thousands ofinjections must be made. However, in accordance with at least someembodiments disclosed herein is the realization that it would not bepractical or efficient to perform hundreds or thousands of injections totreat a given area.

Moreover, when tested with HA gel as the delivery fluid, existingconventional needle array devices were not able to: (1) handle thepressure required to inject the HA-gel-based implant and did showleakage; (2) allow acceptable dosage discrepancy across needles; (3)allow acceptable dosage discrepancy per needle across multiple injectioncycle; (4) perform aspiration to test if at least one of the needle islocated within a blood vessel; and/or (5) keep at minimum the amount ofHA gel that fills, but is not expelled from (and thus lost) within themulti-needle.

Accordingly, in some embodiments, a needle array device is provided thatcan allow for controlled depth of injection. This feature is adjustableduring the manufacturing process (sleeves with different length beingassembled) but non-adjustable by the end user (e.g., the end user mayhave the choice within a range of SKU having different length only).However the depth at which it can deliver gel can be between 500 micronsand 5000 microns.

Further, the device can allow for even flow of product across theneedles attached to the Juvederm needle array. The device can be capableof providing anywhere from 5 μL to 500 μL doses at each injection site.

The device can allow aspiration when located at the injection site, thusmaking it possible for the end user to check if one or more needles arewithin a blood vessel.

The device or procedure can be faster than otherwise possible comparedto procedures using a standard needle and syringe. Additionally, thedevice can work with existing gel packaging techniques (standard sizedsyringes, e.g., 1 mL COC syringe).

In some embodiments, the present disclosure relates to a medical deviceused to provide an injection of a HA-gel-based implant in a patient'sbody simultaneously through multiple mini-invasive surgical procedures.

In some embodiments, the device can comprise a support base having oneor more flow channels that facilitate the delivery of fluid to each ofthe needle tips of the device approximately simultaneously. Further, insome embodiments where the needles have different lengths, theconfiguration of the flow channels to be configured differently fromeach other to ensure that fluid reaches outlet ends of the flow channelsat different moments to tend to ensure that the fluid reaches the tipsof the needles approximately simultaneously.

In some embodiments, the medical device can comprise a needle hubconnector or support or needle base to distribute the product flow tothe multiple needles in an array. The array can comprise at least 2needles (e.g. hypodermic needles) connected to the needle base. Further,the device can comprise a sleeve to define an exposed needle length.

The needle base can be used to split the flow of product coming from thesyringe by the needle hub into various channels pathways to permit fluidflow to reach the tips of each of the individual needles attached tothis needle base. These path ways being design to ensure that theinjected HA-gel-based implant will reach the tips and/or needle apertureto simultaneously enter or exit each needle. Each needle can be designedto ensure that the injected HA-gel-based implant reaches the tip ofthese needles approximately simultaneously.

The sleeve can be used to leave exposed the desired exposed needlelength. During the injection the sleeve can prevent further insertion ofthe needle under the skin, insuring that when the user applies the rightpressure each needle is injecting within the same depth. The sleeve canbe adjustable or interchangeable during the manufacturing process (e.g.,sleeves with different length being assembled into the needle base) butnon-adjustable by the end user (e.g., the end user may have the choicewithin a range of SKU having different lengths only).

An advantage of some embodiments disclosed herein is the ease of use itto inject an HA-gel-based implant at a desired depth and appropriateinjection site distance to each other. The end user just needs to ensurethat the sleeve is in contact with the patient skin across each needle.At each injection at least two injection sites are being treated.

Another advantage of some embodiments disclosed herein is the fact thataspiration could be performed to ensure that the needle is not withinthe blood vessel. The needle array is designed to ensure flow of gel andliquid in both directions and with no air leakage through the gel/liquidchannels.

Yet another advantage of some embodiments disclosed herein is the lowdosage discrepancy across needles and low dosage discrepancy per needleacross multiple injection cycle, which can be due to the flow channeldesign to ensure that the product will reach simultaneously each needle.But also due to the geometry and air tightness of the channels to ensurethat no air bubbles could remain trapped within the needle array.

In accordance with some embodiments disclosed herein, the flow channelsof the support bases can have a round, circular, polygonal, or squarecross-sectional shape.

The following embodiments represent mechanisms that may be used toachieve one or more of the above value propositions. Note that in orderto create a complete device capable of meeting all of the above, one ormore of these embodiments may need to be combined with one another.

Additional features and advantages of the subject technology will be setforth in the description below, and in part will be apparent from thedescription, or may be learned by practice of the subject technology.The advantages of the subject technology will be realized and attainedby the structure particularly pointed out in the written description andembodiments hereof as well as the appended drawings.

It is to be understood that both the foregoing general description andthe following detailed description are exemplary and explanatory and areintended to provide further explanation of the subject technology.

BRIEF DESCRIPTION OF THE DRAWINGS

Various features of illustrative embodiments of the inventions aredescribed below with reference to the drawings. The illustratedembodiments are intended to illustrate, but not to limit, theinventions. The drawings contain the following figures:

FIG. 1 is a front perspective view of a 2×2 needle array device,according to some embodiments.

FIG. 2 is a partially exploded view of a needle array device, accordingto some embodiments.

FIGS. 3A and 3B are exploded views of a needle array device, accordingto some embodiments.

FIG. 4 is an isolated perspective view of a support base of the needlearray device of FIGS. 1-3B, according to some embodiments.

FIG. 5 is a bottom cross-section view of a needle array device along theline 5-5 of FIG. 1 , according to some embodiments.

FIGS. 6A-6D are bottom cross-section views of a needle array device,according to some embodiments.

FIG. 7 is a front perspective view of a 1×4 needle array device,according to some embodiments.

FIG. 8 is an isolated perspective view of a support base of the needlearray device of FIG. 7 , according to some embodiments.

FIG. 9 is a front perspective view of a 1×6 needle array device,according to some embodiments.

FIG. 10 is an isolated perspective view of a support base of the needlearray device of FIG. 9 , according to some embodiments.

DETAILED DESCRIPTION

It is understood that various configurations of the subject technologywill become readily apparent to those skilled in the art from thedisclosure, wherein various configurations of the subject technology areshown and described by way of illustration. As will be realized, thesubject technology is capable of other and different configurations andits several details are capable of modification in various otherrespects, all without departing from the scope of the subjecttechnology. Accordingly, the summary, drawings and detailed descriptionare to be regarded as illustrative in nature and not as restrictive.

The detailed description set forth below is intended as a description ofvarious configurations of the subject technology and is not intended torepresent the only configurations in which the subject technology may bepracticed. The appended drawings are incorporated herein and constitutea part of the detailed description. The detailed description includesspecific details for the purpose of providing a thorough understandingof the subject technology. However, it will be apparent to those skilledin the art that the subject technology may be practiced without thesespecific details. In some instances, well-known structures andcomponents are shown in block diagram form in order to avoid obscuringthe concepts of the subject technology. Like components are labeled withidentical element numbers for ease of understanding.

The present application addresses several operational challengesencountered with needle array devices and related procedures. Thisapplication provides numerous improvements that enable ejection of amedicament from a plurality of needles in an even and balanced manner.For example, in accordance with some embodiments, the presentapplication discloses a needle array device that can be used to eject amedicament from each of a plurality of needles at approximately the sametime, pressure, and/or volume.

Further, some embodiments of the needle array device and relatedprocedures disclosed herein can advantageously control a depth ofinsertion of a plurality of needles in a needle array device, aspirationof an injection site of a plurality of needles in a needle array device,and restrict air from being retained in a medicament pathway of a needlearray device.

Referring to the figures, a needle array device 100 is illustrated inFIGS. 1-3B. A needle array device 100 can comprise needles 102, aremovable protector 104, a sleeve 106, a needle assembly 108, and asupport base 110. Features of some embodiments can be used in a handhelddevice or incorporate other aspects of copending U.S. Patent ApplicationPublication US2016/0095984A1, the entirety of which is incorporatedherein by reference for all purposes.

The needle array device 100 can comprise a plurality of needles 102. Theneedles 102 are configured to be inserted into a patient and to direct amedicament into the patient in situ. Although this application describesthe medicament as a gel, the medicament can be substance configured tobe ejected by a needle, including, liquids and gasses. In some examples,the medicament is an injectable hyaluronic acid gel.

The plurality of needles 102 of the needle array device 100 can includetwo or more needles 102 arranged in a pattern. The needles 102 can bearranged in a symmetrical pattern, for example a square, circle, orstraight line, or a non-symmetrical pattern. Referring to FIGS. 2-3B,four needles 102 are arranged approximately as a square forming a 2×2pattern.

The needles 102 can include a base portion and a tip portion. The baseportion can be coupled to a portion of the needle array device 100 sothat the tip portion extends away from the needle array device 100. Apassage extends through each needle 102, from the base portion throughthe tip portion. The passage directs a medicament through the needle forejection at the tip portion. In some examples, the tip portion comprisesa beveled surface with the passage extending through the bevel. Thebeveled surface of the tip portion can facilitate piercing the skin orother surface of a patient.

The needles 102 can be at least about 34 gauge and/or less than or equalto about 20 gauge. In some examples, the needle size is between at leastabout 34 gauge and/or less than or equal to about 23 gauge.

The needle array device 100 can include a removable protector 104configured to prevent unintentional contact with the needles 102. Theremoval protector 104 can comprise a cover plate 152 and walls 154 thatextends over an outer surface of the needles 102.

The size and shape of the removal protector 104 corresponds to thearrangement of the needles 102. The cover plate 152 comprises a sizesufficient to extend across the tip portions of each of the needles 102.The walls 154 are positioned to correspond with the arrangement of theneedles 102 so that the walls 154 extend over a needle 102 when theremovable protector 104 is coupled with the needle array device 100.

The walls 154 can extend from the cover plate 152 and comprise acylindrical cross-section having one or more notches. Referring to FIGS.1-3B, cylindrically shaped walls 154 are positioned in a 2×2 patternwith a longitudinal axis of each cylindrical wall aligned with alongitudinal axis of each needle 102. Further, in some embodiments,openings through the removable protector 104 are aligned with thelongitudinal axis of each needle 102.

A cross-sectional inner profile of the cylindrical walls 154 isconfigured to receive a portion of the needle array device 100. In someembodiments, the cross-sectional inner profile of the cylindrical walls154 is approximately equal to or less than an outer surface of theneedle array device 100.

When the removable protector 104 is coupled with the needle array device100, the notches permit portions of the wall 154 to be urged to providean interference fit between the removable protector 104 and the needlearray device 100. Although interference fit between the removableprotector 104 and the needle array device 100 is described, other meansof coupling can be implemented. For example, the removal protector 104can be coupled with the needle array device 100 using a mechanicalconnection or adhesive. In some embodiments, the removal protector 104and the needle array device 100 can be unitarily formed with abreak-away portion or living hinge.

The needle array device 100 can include a sleeve 106 configured to limitthe depth that the needles 102 can be inserted into a patient. Dependingon the type of procedure or treatment, a user can select a sleeve 106for coupling with the needle array device 100 to achieve a desiredinjection depth. The depth that the needles 102 can be inserted into apatient is limited by the length of the portion of each needle 102 thatextends beyond an outer surface of the sleeve 106. When the plurality ofneedles 102 are advanced into the patient, contact of the outer surfaceof the sleeve 106 against the patient and prevents further insertion ofthe needles 102.

The size and shape of the sleeve 106 can be based on the number andarrangement of the plurality of needles 102. Referring to FIGS. 1-3B,the sleeve 106 comprises a proximal portion and a distal portion. Aninner cavity extends from the proximal portion toward a distal portion.The inner cavity is configured to receive a portion of the needles 102and can comprise a cross-sectional profile that is approximately equalto or greater than a perimeter around the plurality or needles 102.

The distal portion of the sleeve 106 comprises a plurality of heads,each head having an opening 202 to permit a portion of the needles 102to extend therethrough. The openings 202 are positioned in a patternthat corresponds with the arrangement of the plurality of needles 102.For example, the openings 202 of the sleeve illustrated in FIGS. 1-3Bare positioned in a 2×2 square pattern.

The length of the portion of each needle 102 that is exposed or extendsbeyond an outer surface of the head of the sleeve 106 depends on thelength (or height) of the sleeve 106, which can be measured from theproximal portion to an outer surface of the sleeve at the distalportion. If the head or sleeve length (or height) increases, the exposedlength of the needle 102 decreases, and conversely, the head or sleevelength decreases, the exposed length of the needle 102 increases.Accordingly, in some embodiments, needle array kits can be provided inwhich a variety of sleeves having different head or sleeve lengths canbe configured to couple with the needle array device 100. A sleeve 106having a particular length can be selected to limit the depth that theneedles 102 can be inserted into a patient. For example, when a sleeve106 having a short length, relative to the length of the needles 102, iscoupled with the needle array device 100, the portion of each needle 102that extends beyond an outer surface of the sleeve 106 is greatest.Therefore the depth that the needles 102 can be inserted into a patientis greatest. To the contrary, when a sleeve 106 having a long length,relative to the length of the needles 102, is coupled with the needlearray device 100, the portion of each needle 102 that extends beyond anouter surface of the sleeve 106 is minimal. Therefore the depth that theneedles 102 can be inserted into a patient is minimal.

In some examples, the sleeve 106 can comprise individual wall portionsthat extend around each needle 102. An outer surface of the sleeve 106can comprise a plurality of concave portions. The number and position ofeach concave portion corresponds with the number and arrangement of theplurality of needles 102, such that a needle 102 extends through each ofconcave portion.

Depending on the sleeve 106 coupled to the needle array device 100, theneedles 102 can extend beyond an outer surface of the sleeve 106 toprovide an exposed height. The exposed height of a needle 102corresponds to a depth that the needle 102 can be inserted into apatient. A needle 102 can have an insertion depth of at least about 0.5mm and/or less than or equal to about 5 mm. In some examples, theneedles 102 can extend beyond an outer surface of the sleeve 106 by atleast about 1.5 mm and/or less than or equal to about 3.5 mm. In someembodiments, the needles 102 have an exposed height between about 1 mmand about 5 mm, between about 2 mm and about 4 mm, or about 3 mm.

After the needles 102 have been inserted into a patient, a user mayoptionally perform an aspiration gesture to ensure that the needles 102are not within a blood vessel. If no blood is seen within a Luerconnector of the needle array device 100 and/or syringe coupled to theneedle array device 100, the user can proceed to injection themedicament.

The needle array device 100 can include a needle assembly 108 comprisinga needle base 252, and two or more needle columns 254 and needles 102.

The needle base 252 can comprise an upper portion and a lower portion.the upper portion can comprise a top surface, and the lower portion cancomprise a bottom surface. The needle columns 254 extend from the topsurface of the needle base 252 and are configured to support the needles102. Each needle column 254 can comprises a protrusion or shaft thatextends from the needle base 252 with a needle 102 extending from eachneedle column 254. One or more wings extend radially outward from theshaft of the needle column 254 to provide support or buttressing. Insome embodiments, the needle column 254 can comprises a cone shapehaving a cross-sectional profile that tapers away from the needle base252.

The needle columns 254 are positioned, relative to each other, to formthe arrangement of the plurality of needles 102. For example, fourneedle columns 254 can extend from the needle base 252 in a generallysquare pattern to form the 2×2 arrangement illustrated in FIGS. 3A and3B. The number of needle columns 254 and their position on the needlebase 252 is not limited to a 2×2 arrangement. In should be understoodthat embodiments of the present application can comprise needle columns254 and needles 102 positioned to form a variety of arrangements thatcan include, but are not limited to, a 1×4, a 1×6, or a 2×4 array.Further, the needle columns 254 and needles 102 can be positioned toform a variety arrays, including circles, triangles, parabolas, andirregular or non-symmetrical arrays. Depending on the type of procedureor treatment, a user can select a needle array device having desiredneedle arrangement pattern, spacing between needles, and possible needleinsertion depth.

The needles 102 are be positioned an equal distance apart from eachother. The needles 102 can be positioned, relative to each other, with adistance of at least about 3 mm and/or less than or equal to about 32mm. In some examples, a distance between each of the needles 102 is atleast about 5 mm and/or less than or equal to about 30 mm.

Although the top surface of the needle base 252 are illustrated assubstantially planar with the tip portions of the needles 102 positionedon a 2D or common plane, it shall be understood that the shape of needlebase 252 and/or length of the needles 102 can vary, such that the tipportions of the needles are non-planar and provide a curved fluiddistribution system. For example, the needle base 252 can comprise asaddle-shape with the tip portions of each needle positioned at pointsalong a curved plane. In another example, the needle base 252 can besubstantially planar with the plurality of needles 102 having differentlengths, such that the tip portions of each needle are positioned atpoints along a curved plane.

Referring to FIG. 3B, the needle base 252 can comprise needle apertures256 that are in fluid communication with each of the needles 102. Theapertures 256 can extend from the bottom surface to the top surface ofthe needle base 252 to permit a medicament to be directed through theneedle base 252 to each needle 102. Each aperture 256 comprises across-sectional inner profile that defines the size of the aperture. Thesize of the aperture can be configured to regulate a flow rate and/orvolume of a medicament that is directed into each respective needle 102.The needle base 252 can comprise apertures 256 having substantially thesame size to provide an even or balanced ejection of medicament from theneedles. The apertures, in some embodiments, can have different sizes toprovide an even or balanced ejection of medicament from the needles whena fluid path to one or more needle 102 comprises different features,such as length, width, or cross-sectional profile.

The needle assembly 108 can comprise coupling members and orientationfeatures to facilitate coupling between portions of the needle arraydevice 100. To couple the needle assembly 108 with the sleeve 106, theneedle base 252 can comprise a clip 258. In some examples, two clips 258extend from the top surface at opposite sides of the needle base 252.The clips 258 can comprise an interface surface having a protrusion 260configured to engage another portion of the needle array device 100.

The outer surface of the sleeve 106 comprises a coupling channel 262configured to receive the clip 258 therein when the sleeve 106 iscoupled with the needle base 252. The channel 262 can include a ridge264 configured to retain the sleeve 106 with the needle base 252, andresist separation or movement of the sleeve 106 away from the needlebase 252.

When the sleeve 106 is coupled with the needle base 252, the protrusion260 can extend over or past the ridge 264 to engage against the ridge264. Any of the clip 258, the protrusion 260, the channel 259, and theridge 264 can be flexible to permit separation of the sleeve 106 fromthe needle base 252. For example, the clips 258 can be urged away froman outer surface of the sleeve 106 to couple the needle assembly 108with the sleeve 106, and can be urged away from the outer surface of thesleeve 106 to separate the needle assembly 108 from the sleeve 106.

In some embodiments, the support base 110 and/or the sleeve 106 cancomprise a clip 258 configured to engage the other of the support base110 and the sleeve 106. When the support base 110 and the sleeve 106 arecoupled together, the needle base 252 can be retained therebetween.

To facilitate orientation of the needle assembly 108 with anotherportion of the needle array device 100, the needle base 252 can comprisean orientation feature. The orientation feature can include any of anotch, aperture, pin, and ridge, or combination thereof. Referring toFIGS. 3A and 3B, notches 266 extend from opposing outer side surfacesinto the needle base 252. The notches 266 are configured to receive aridge 268 that extends from the support base 110. In some embodiments,the orientation feature includes an aperture that extends through theneedle base 252. The aperture 270 is configured to receive a locatingpin 272 that extends from the support base 110. The position of one ormore aperture 270 and locating pin 272 limits the potential orientationof the needle base 252 relative to the support base 110 when the needlebase 252 and support base 110 are coupled together.

Referring now to FIGS. 3B and 4 , the needle array device 100 includes asupport base 110 configured to couple to the needle assembly 108. Thesupport base 110 comprises a Luer connector 302 for coupling to asyringe device, and a fluid manifold 304 defining a fluid pathway fordirecting a medicament between the Luer connector 302 and the pluralityof needles 102. In some embodiments, the support base 110 comprises anupper portion comprising the fluid manifold 304, and a lower portioncomprising the Luer connector 302.

The Luer connector 302 comprises an entrance aperture 303 extendingthrough the Luer connector 302 toward the fluid manifold 301, anddefining a fluid pathway between the Luer connector 302 and the fluidmanifold 301. The Luer connector 302 can be configured to couple with a0.8 mL or 1 mL syringe manufactured by Allergan plc of Dublin, Ireland.The Luer connector 302 can comprise features disclosed in InternationalPatent Application No. PCT/US2009/066427, the disclosure of each ofwhich is incorporated herein by reference in its entirety for allpurposes.

The upper portion of the support base 110 can be coupled to the lowerportion of the needle base 252 to form a fluid distribution cavitytherebetween. When the support base 110 and the needle base 252 arecoupled together, the entrance aperture 303 and each of the plurality ofneedle apertures 256 are fluidly coupled with the fluid distributioncavity.

The fluid manifold 304 comprises an inflow aperture 306 and flowchannels 308. Four flow channels 308A, 308B, 308C, and 308D extend awayfrom the inflow aperture 306. However, it should be understood that oneor more flow channel 308 can be oriented in any direction and/orconfiguration fluidly coupled with the inflow aperture 306.

The inflow aperture 306 is fluidly coupled with the Luer connector 302and the flow channels 308, such that a volume of a syringe coupled tothe needle array device 100 is in fluid communication with the flowchannels 308. The fluid manifold 304 defines a portion of defines orforms a portion of the fluid distribution cavity. In some embodiments,the fluid manifold 304 forms the side walls of the fluid distributioncavity, an upper surface of the support base 110 forms the bottomsurface of the fluid distribution cavity, and a bottom surface of theneedle base 252 forms fluid distribution cavity.

The flow channels 308 form a fluid pathway that directs a fluid frominflow aperture 306 toward the needle apertures 256. The flow channels308 can divide or branch the fluid pathway from inflow aperture 306toward one or more of the plurality of needles 102. The flow channels308 comprise a profile and form a boundary pattern to enable amedicament to be driven uniformly and arrive at all the apertures of thetip portions of the needles 102 approximately simultaneously, such thatthe medicament is ejected from all needles 102 approximately at sametime, same pressure, and/or same volume. As a result, some embodimentscan advantageously ensure that there is a low dosage discrepancy betweenthe needles (e.g., that the dosage or fluid outflow from each of theneedles is approximately equal) when medicament or fluid is ejectedtherefrom.

The flow channels 308 can be formed as concave portions or a groove thatextends into a surface of the support base 110. Referring to FIG. 4 ,the flow channels 308 are formed by walls that extend from a top surfaceof the support base 110. A bottom surface and perimeter of the flowchannels 308 can be defined by the support base 110, and a top surfaceof the flow channels 308 can be formed by the needle base 252 when thesupport base 110 is coupled with the needle assembly 108. In someexamples, the flow channels 308 can be formed by a bottom portion orsurface of the needle base 252.

Each flow channel 308 can define a pathway that extends from the inflowaperture 306 to one or more needle 102. In some examples, the flowchannel 308 can comprise a first portion and a second portion thatcomprises branches. The first portion extends from the inflow aperture306 toward the second portion of the flow channel 308. The secondportion of the flow channel 308 comprises branches that extend away fromthe first portion. Each branch can extend from the first portion of theflow channel 308 toward one or more of the needles 102.

In some examples, the fluid manifold 304 can comprise one or morepassages that extend through the support base 110. For example, thefluid manifold 304 can comprise a passage that extends from the Luerconnector 302 to each of the plurality of needles 102. For example, thefluid manifold 304 comprises an inflow aperture that extends through thesupport base 110.

The inflow aperture 306 extends through the support base 110 to providea passage from the Luer connector 302 to the flow channels 308. The flowchannels 308 extend outward from the inflow aperture 306 toward theneedles 102 so that a single stream of a medicament is diverted intomultiple streams. For example, a single stream of a medicament directedthrough the inflow aperture 306 enters the fluid manifold 304 and isthen diverted to each flow channel 308.

The inflow aperture 306 is positioned to enable use with a particularneedle array arrangement or is positioned adjacent to or coupled withthe Luer connector 302. The inflow aperture 306 can be positioned in acenter of the support base 110 or offset from the center of the supportbase 110. Referring to FIG. 4 , the inflow aperture 306 is positioned atthe approximate center of the support base 110 with each of the flowchannels 308 extending symmetrically outward from the inflow aperture306. However, the inflow aperture 306 can be positioned offset from thecenter of the support base 110 with flow channels 308 extending from theoffset inflow aperture 306 toward each needle 102.

Each flow channel 308 forms a shape that includes a length and across-sectional profile. The flow channel 308 comprises a plurality offlow channels or area having a width and/or depth. The cross-sectionalprofile can be oriented transverse to the length of the flow channel308. The cross-sectional profile or shape of the flow channel 308 can beconfigured for the medicament to be ejected from all needles 102approximately at same time, same pressure, and/or same volume.

The length of each flow channel 308 can extend from a proximal portionat the inflow aperture 306 to a distal portion where the fluidpassageway extends from the flow channel 308 to a needle 102. The lengthof the flow channel 308 can refer to a length of a fluid path betweenthe inflow aperture 306 and an aperture 256 of the needle base 252. Insome embodiments, the length of each flow channel 308 can define alength of the fluid pathway from the inflow aperture 306 to the needles102.

To cause a medicament to be ejected from all needles 102 atapproximately the same time, same pressure, and/or same volume, eachflow channel 308 can have approximately the same length. Where thedistance between the inflow aperture 306 and the apertures 256 is thesame for each of the needles 102, each flow channel 308 can have thesame length. The approximately equal length or distance of the fluidpath can cause a fluid to reach tips of the needles 102 approximatelysimultaneously, thus tending to ensure a low dosage discrepancy.

In some embodiments, each flow channel 308 can extend symmetrically fromthe inflow aperture 306 to the needles 102. However, where the distancebetween the inflow aperture 306 and the apertures 256 is different forsome of the needles 102, one or more flow channel 308 can have the samelength and extend along a tortuous path.

In some embodiments, the length of the fluid path from the inflowaperture 306 to a first needle aperture is approximately equal to alength of the fluid path from the inflow aperture 306 to a second needleaperture. The approximately equal lengths of the fluid paths can cause afluid to reach tips of the first and second needles 102 approximatelysimultaneously. Such embodiments can be used to deliver a fluidsimultaneously to tips of the needles when the needles are the samelength as each other.

However, in some embodiments, the needles may have differing lengths,which would require the fluid to be distributed through the flowchannels and reach needle apertures at different moments (e.g., beforeor after fluid reaches other needle apertures) so that the fluid canreach the tips of all of the needles approximately simultaneously. Forexample, in some embodiments, the length of the fluid path from aninflow aperture to a first needle aperture may be different than alength of the fluid path from the inflow aperture to a second needleaperture. The different lengths of the fluid path can cause a fluid toreach the needle apertures at different moments, but can to ensure thatthe fluid reaches the tips of the first and second needles approximatelysimultaneously. Further, other aspects of the fluid paths can bemodified, such as the volume or cross-sectional shape to tend to causethe fluid to reach the needle apertures at different moments and causethe fluid to reach the needle tips approximately simultaneously.

The cross-sectional profile or shape of the flow channels 308 can beconfigured to cause a medicament to be ejected from all needles 102 atapproximately the same time, same pressure, and/or same volume. Thecross-sectional profile of the flow channels 308 can be uniform orvaried along the fluid pathway, thereby effecting flow characteristicsof a medicament.

To increase a resistance to medicament flow through a portion of thefluid pathway, a flow channel 308 may comprise a portion having areduced cross-sectional profile relative to other portions of the flowchannel 308 or other flow channels 308. The reduced cross-sectionalprofile of the flow channel 308 can increase resistance and/or pressurealong a length of the fluid path.

A flow channel 308 can have a smaller cross-sectional area than thereservoir 307 for increasing the flow resistance through the flowchannel 308. In some embodiments of the present disclosure, the width ofthe reservoir 307 is at least twice as large as a width of the flowchannels 308. In some embodiments, each of the flow channels 308 has anapproximately constant cross-sectional area.

In contrast, to reduce resistance to medicament flow, a flow channel maycomprise a portion having a larger cross-sectional profile relative toother portions of the flow channel 308 or other flow channels 308.

The fluid path from the inflow aperture 306 to each needle aperture 256or needle 102 can comprise a pathway volume. The pathway volume of eachfluid path can be defined by the cross-sectional profile or shape ofeach flow channel. The cross-sectional profile or shape of each flowchannel can include any of the length, the width, and the depth of therespective flow channel. Optionally, the pathway volume can also includethe volume of the fluid reservoir. However, the pathway volume can bedefined as the volume of the flow channel along which the fluid pathextends from the fluid reservoir to the respective flow channel outletend.

To cause a medicament to be ejected from all needles 102 atapproximately the same time, same pressure, and/or same volume, thepathway volume of the fluid path or flow channel 308 can beapproximately equal. In accordance with some embodiments, the pathwayvolumes of the fluid pathways of a support base can be approximatelyequal to each other. By “approximately equal,” the pathway volumes canhave respective volumes that are within about 20% of each other, about15% of each other, about 12% of each other, about 10% of each other,about 8% of each other, about 6% of each other, about 4% of each other,or about 2% of each other. In some embodiments, the largest and thesmallest pathway volumes of all of the fluid pathways of a support basecan be approximately equal to each other.

In some embodiments, a fluid path from the inflow aperture 306 to afirst needle aperture comprises a first pathway volume, and a fluid pathfrom the inflow aperture 306 to a second needle aperture comprises asecond pathway volume. To cause a medicament to be ejected from allneedles 102 approximately equally, or at approximately the same time,same pressure, and/or same volume, the first pathway volume can beapproximately equal to or different than the second pathway volume,depending on needle length.

In some embodiments of the present disclosure, the fluid reservoir 307comprises a volume. The volume of the fluid reservoir 307 can optionallybe larger than the volumes of each of the plurality of flow channels308. As a general principle, fluid will flow in the direction of leastresistance, thus filling areas of the fluid reservoir or flow channelsthat offered the lowest degree of resistance to fluid flow. As thevolume of medicament accumulating in the fluid reservoir 407 increases,some of the medicament will begin to be directed into one or more flowchannels 308. Thus, the larger volume of the fluid reservoir 307,relative to each of the plurality of flow channels 308, permits a fluidor medicament to accumulate in the fluid reservoir 307 and move towardeach of the flow channels 308 before moving into and along the pluralityof flow channels 308 toward a needle aperture 256. Accumulation of themedicament in the fluid reservoir 307 can facilitate ejection of themedicament from all needles 102 approximately equally, or atapproximately the same time, same pressure, and/or same volume.

To achieve ejection of a medicament from all needles 102 atapproximately the same time, same pressure, and/or same volume, anycombination of flow channel 308 length and cross-sectional profile canbe implemented. In some examples, the flow channel 308 can compriseadditional or alternative features, structures, or surface finishes thatcan affect flow characteristics of a medicament. The flow channel 308orientation and pattern can comprise any shape consistent with achievingthe distribution of a medicament to the needles 102. One or more flowchannel 308 pattern is possible with a particular needle arrangementpattern. For example, a 2×2 needle arrangement array can comprise flowchannels 308 forming an “X” shape. In some embodiments of the presentdisclosure, the flow channels 308 form or a zig-zag shape or concentricspirals similar to a camera aperture.

The fluid manifold 304 can comprise a fluid reservoir 307 between theinflow aperture 306 and the flow channels 308. The fluid reservoir 307is configured to receive a medicament from the inflow aperture 306 andprovide a cavity where the medicament can accumulate and move into theflow channels 308.

The position of the fluid reservoir 307 and the inflow aperture 306 arealigned relative to each other so that the fluid reservoir 307 is influid contact with the inflow aperture 306. The fluid reservoir and theinflow aperture 306 can be positioned with the inflow aperture 306 in acenter of the fluid reservoir 307. In some embodiments, the fluidreservoir 307 and the inflow aperture 306 are positioned with the inflowaperture 306 offset from a center of the fluid reservoir 307.

The fluid reservoir 307 can be formed as a portion of the flow channels308 or as a separate cavity that is fluidly coupled with the flowchannels 308. The fluid reservoir 307 can be formed by proximal portionsof the flow channels 308 that intersect or are coupled together. Theflow channels 308 can extend from the fluid reservoir toward the needles102. In some examples, the fluid reservoir 307 can be formed by aportion of the flow channel that comprises an increasing and/ordecreasing cross-sectional profile.

Referring to FIG. 4 , the fluid reservoir 307 and the inflow aperture306 are positioned in a center of the support base 110. The fluidreservoir 307 is formed by proximal portions of the flow channels 308that are coupled together to form a closed cavity. The width of the flowchannels 308 narrows or tapers away from fluid reservoir 307 toward adistal portion of each flow channel 308.

The flow channels 308 can extend in a direction away from the inflowaperture 306. The flow channels 308, illustrated in FIGS. 4 and 5 , forman X-shape or cross-shape pattern with the reservoir 307 being disposedat a central position of the cross-shaped pattern.

In some embodiments, the needle array device 100 can comprise two ormore fluid reservoirs 307. The needle array device 100 can comprise twofluid reservoirs 307, each fluidly coupled with a group of flow channels308. Where the flow channels 308 comprise one or more branches, the oneor more branches can comprise a fluid reservoir 307. In some examples, afluid reservoir can be positioned along one or more flow channel 308.

Referring to FIG. 5 , a cross-sectional view of the needle array device100 through line 5-5 of FIG. 1 illustrates the fluid distributionsystem. The fluid distribution system includes the fluid manifold 304formed by the flow channels 308 of the portions of the support base 110and the needle base 252 of the needle assembly. The flow channels 308and the inflow aperture 306 are illustrated in hash-lines to indicatethe location of the inflow aperture 306 relative to the fluid reservoir307, the flow channels 308, apertures 256, and needles 102.

The inflow aperture 306 and fluid reservoir 307 are centrally locatedwith the flow channels 308 extending from the fluid reservoir 307 to theapertures 256. When a medicament is directed into the fluid distributionsystem through the inflow aperture 306, the medicament can accumulate inthe fluid reservoir. As the volume of medicament accumulating in thefluid reservoir increases, some of the medicament will be directed intoone or more flow channel 308. Because the fluid reservoir 307 comprisesa cavity having a larger cross-sectional profile, relative to the flowchannels 308, the medicament can be distributed to each of the remainingempty flow channels 308.

The flow of a medicament through the fluid distribution system isillustrated in FIGS. 6A-6D, which illustrate different stages of themovement and distribution of a medicament M relative to the needles 102,the apertures 256, the inflow aperture 306, the fluid reservoir 307, andthe flow channels 308.

FIG. 6A illustrates the medicament M directed from the inflow aperture306 (shown in hashed-lines) into a fluid reservoir 307. Flow channels308 extend from the fluid reservoir to the apertures 256. Because thefluid reservoir 307 comprises a larger cross-sectional profile or width,relative to the cross-sectional profile or width of the flow channels308, the resistance to flow within the fluid reservoir 307 is minimal.In the fluid reservoir 307, the medicament M accumulates in the fluidreservoir 307 and the outer edge or boundary layer of the medicament Mbegins to flow toward the flow channels 308.

In FIG. 6B, the medicament M has fully filled the fluid reservoir 307and a portion of the medicament M has flowed into at least one flowchannel 308A. Because the flow channel 308A has a greater resistance toflow, relative to the fluid reservoir 307, additional medicament Mdirected into the fluid reservoir 307 can move toward the other flowchannels 308B, 308C, and 308D. As the medicament M is directed into thefluid reservoir 307, the boundary layer moves toward the needles 102 ata distal portion of each flow channel 308A, 308B, 308C, and 308D.

Referring now to FIG. 6C, the boundary layer of the portion of themedicament M that entered the flow channel 308A in FIG. 6B has remainedstationary due to an increasing resistance to flow along the length ofthe flow channel 308A. The increased resistance to flow at a distalportion of the flow channel 308A, and the accumulation of medicament Min the fluid reservoir, cause the medicament M to move toward a path oflesser resistance. Accordingly, a portion of the medicament M has nowflowed into each of the flow channels 308B, 308C, and 308D.

At FIG. 6D, the medicament M is evenly distributed between the inflowaperture 306 and the aperture 256 of each flow channel 308A, 308B, 308C,and 308D. Because the medicament M is evenly distributed in the flowchannels 308A, 308B, 308C, and 308D, additional medicament M directedinto the fluid distribution system will cause medicament M to movethrough the aperture 256 to the needles 102 to be ejected from allneedles 102 at approximately at same time, same pressure, and/or samevolume.

To determine the amount or volume of medicament ejected using the needlearray device 100, the amount of medicament ejected from a syringecoupled to the needle array device 100 can be divided by the number ofneedles 102. For example, if 40 μL of medicament is ejected from thesyringe, and if the needle array device 100 comprises four needles 102,each needle 102 could have ejected 10 μL of medicament.

Referring now to FIGS. 7 and 8 , an embodiment of a needle array device400 comprising four needles arranged in a 1×4 pattern is illustrated.The needle array device 400 comprises general features of the 2×2 needlearrangement pattern illustrated in FIGS. 1-6 , and includes a pluralityof needles 402, a removable protector 404, a sleeve 406, a needleassembly 408, and a support base 410. The general features of the needlearray device 400 in common with the needle array device 100 are notrepeated here for clarity and brevity, but are incorporated here byreference.

The support base 410, illustrated in FIG. 8 , comprises a fluiddistribution system configured to distribute a medicament to the needlearray device 400 comprising a 1×4 needle arrangement pattern. Thesupport base 410 comprises a fluid pathway for directing a medicamentbetween a Luer connector and the plurality of needles 402.

The support base 410 comprises an inflow aperture 452, a fluid reservoir407, and flow channels 454. The inflow aperture 452 and fluid reservoir407 can be positioned at an approximate center of the support base 410with the flow channels 454 extending from the fluid reservoir 407. Somefeatures and characteristics of the fluid distribution system thatdictate the flow of a medicament are the same as those discussedelsewhere in this application. Accordingly, some common features andcharacteristics are not repeated here for clarity and brevity, but areincorporated here by reference.

Each flow channel 454 can comprise a shared portion or segment 456 and aplurality of terminal portions or segments 458, 460. FIG. 8 shows twoterminal segments 458, 460 splitting from an end of the shared segment456; however, more than two terminal segments can split from the sharedsegment 456 in some embodiments. The shared segment 456 extends awayfrom the fluid reservoir 407 toward the terminal segments 458, 460. Theflow channel 454 can branch into the terminal segments 458, 460 todivide the flow channel 454 from a single fluid path (i.e., the sharedsegment 456) into two fluid paths (e.g., terminal segments 458, 460).

Each terminal segment 458, 460 can comprise an inlet portion that is influid communication with a terminal end 464 of the shared segment 456.Further, each terminal segment 458, 460 can also comprise an outlet end466, 468 that is in fluid communication with a respective needleaperture or needle. The outlet end 466, 468 of each of the terminalsegments 458, 460 can form an end point of the flow channel 454. Theoutlet end 466, 468 of the terminal segments 458, 460 is positioned at alocation where a needle 402 is fluidly coupled with the fluiddistribution system. In some embodiments, the outlet end 466, 468 isaligned approximately with the needle aperture of the needle base. Theoutlet end 466, 468 of each of the terminal segments 458, 460 can bealigned along a straight line extending through each of the terminalsegments 458, 460.

Each fluid path can extend between the inflow aperture 452 and one ormore flow channel outlet ends. A fluid path can comprise the sharedsegment 456 and a plurality of terminal segments 458, 460 of the flowchannel. For example, the plurality of terminal segments can comprisetwo, three, four, or more terminal segments. Because fluid paths towardeach of the respective needles can be branched away from other fluidpaths in accordance with some embodiments, at least a portion of a fluidpath toward a given needle can be shared with another fluid path. Forexample, a first fluid path can comprise the shared segment 456 incombination with the terminal segment 458, and a second fluid path cancomprise the same shared segment 456 in combination with the terminalsegment 460.

Further, in accordance with some embodiments, each fluid path canterminate at an outlet end. As illustrated, the first flow path canterminate in a first outlet end 466, and the second flow path canterminate in a second outlet end 468.

In accordance with some embodiments, any of the support bases disclosedherein can be configured to include one, two, or more flow channels. Forexample, the support base 110 comprises four flow channels. Further, thesupport base 410 can include a second flow channel 470. Moreover,support base 510 (shown in FIG. 10 and discussed further below)comprises three flow channels. Flow channels of any of the embodimentsdisclosed herein, such as the support base 110, the support base 410,and/or the support base 510 can include flow channels that includefeatures such as those discussed with respect to the flow channel 454.

For example, the second flow channel 470 of the support base 410 in FIG.8 can comprise the features discussed with reference to flow channel454, including a shared segment having a terminal end, as well asterminal segments having outlet ends. The features of the second flowchannel 470 in common with the flow channel 454 are not repeated herefor clarity and brevity, but are incorporated here by reference. Thefeatures of flow channel 454 can also be applied to other embodiments ofthe present disclosure, including embodiments shown in FIGS. 1 and 10 .

Moreover, the support base of any of the embodiments disclosed hereincan comprise flow channels having multiple fluid paths. Each fluid pathcan lead from an inflow aperture or fluid reservoir toward a respectiveneedle aperture. Thus, for example, the support base 110 comprises fourfluid paths that each lead to a respective needle aperture, the supportbase 410 also comprises four fluid paths that each lead to a respectiveneedle aperture, and the support base 510 comprises six fluid paths thateach lead to a respective needle aperture.

In accordance with some embodiments, each fluid path can have a length,which can be measured as the distance within the flow channel betweenthe inflow aperture and the flow channel outlet end. The length can be adirect or shortest distance between the inflow aperture and the outletend. For example, as illustrated in FIG. 8 , the length of the firstfluid path (the combination of the shared segment 456 and the terminalsegment 458) can be the shortest path through the flow channel 454,between the inflow aperture 452 to the flow channel outlet end 466. Insome embodiments, the length of a fluid path includes a length betweenthe inflow aperture and the aperture of the needle base or the needle.

Each fluid path can comprise a pathway volume. The pathway volume caninclude portions of the flow channel. Optionally, the pathway volume canalso include the volume of the fluid reservoir. However, the pathwayvolume can be defined as the volume of the flow channel along which thefluid path extends from the fluid reservoir to the respective flowchannel outlet end.

For example, the first fluid path can define a first pathway volume,which can be the summation of the volume of the shared segment 456 andthe volume of the terminal segment 458. Similarly, the second fluid pathcan define a second pathway volume, which can be the summation of thevolume of the shared segment 456 and the volume of the terminal segment460. Thus, in determining a pathway volume of a fluid path, multiplefluid paths may have a volume that is based on a volume of a common orshared portion of a flow channel or fluid reservoir.

In accordance with some embodiments, the pathway volumes of the fluidpathways of a support base can be approximately equal to each other. By“approximately equal,” the pathway volumes can have respective volumesthat are within about 20% of each other, about 15% of each other, about12% of each other, about 10% of each other, about 8% of each other,about 6% of each other, about 4% of each other, or about 2% of eachother. In some embodiments, the largest and the smallest pathway volumesof all of the fluid pathways of a support base can be approximatelyequal to each other.

With continued reference to FIG. 8 , in some embodiments, the sharedsegment 456 of the flow channel can define a shared pathway volume, andthe terminal segments 458, 460 of the flow channel can each define arespective terminal pathway volume. The shared pathway volume can beapproximately equal to the terminal pathway volume. However, in someembodiments of the present disclosure, the terminal pathway volume ofthe flow channel can be less than the shared pathway volume of the flowchannel. The shared pathway volume and the terminal pathway volume canbe less than a volume of the fluid reservoir 407. The relative pathwayvolumes of a fluid path can provide resistance to medicament flowthrough the fluid distribution system. As a medicament is directed alonga fluid path, resistance to movement of the medicament can be greateralong the shared segment 456 of the flow channel relative to the fluidreservoir 407. A resistance to movement of the medicament can also begreater along the terminal segments 458, 460 relative to the sharedsegment 456. Thus, a decreasing pathway volume along a fluid path cancreate an increasing degree of resistance to fluid travel as the fluidmoves further along the fluid path, such as when the fluid reaches thereaches the shared segment and/or terminal segments. In someembodiments, such configurations can advantageously facilitate anobjective of the present disclosure, which is to tend to ensure thatfluid is delivered to each of the needle tips approximatelysimultaneously, thus tending to ensure a low dosage discrepancy.

For example, when a medicament is directed into the fluid distributionsystem through the inflow aperture 452, the medicament can accumulate inthe fluid reservoir 407. As a general principle, the fluid will flow inthe direction of least resistance, thus filling areas of the fluidreservoir or flow channels that offered the lowest degree of resistanceto fluid flow. As the volume of medicament accumulating in the fluidreservoir 407 increases, some of the medicament will begin to bedirected into one or more flow channels 454, 470. Because the fluidreservoir 407 comprises a cavity having a larger cross-sectional profilethan the flow channels 454, 470, the medicament will tend to bedistributed toward all of the flow channels 454, 470 before advancinginto or far along the flow channels 454, 470. Resistance to flow alongany of the shared segment and the terminal segments, as well as theaccumulation of medicament in the fluid reservoir, can cause themedicament to move into and evenly fill the flow channels 454, 470. Withmedicament evenly distributed in the flow channels 454, 470, additionalmedicament directed into the fluid distribution system will cause themedicament to move through the needles 402 to be ejected from allneedles 402 at approximately at same time, same pressure, and/or samevolume. Further, in some embodiments where the needles have differentlengths, the configuration of the flow channels can be modified toensure that fluid reaches outlet ends of the flow channels at differentmoments to tend to ensure that the fluid reaches the tips of the needlesapproximately simultaneously.

The fluid reservoir 407 comprises a larger cross-sectional profile orwidth, relative to the cross-sectional profile or width of the sharedsegment 456 of the flow channel 454. In some embodiments, the sharedsegment 456 comprises a larger cross-sectional profile or width,relative to the cross-sectional profile or width of the terminalsegments 458, 460 of the flow channel. In some examples of the presentdisclosure, the cross-sectional profile or width of the fluid reservoir407, and/or the cross-sectional profile or width of the flow channels454, 470, can taper from the inflow aperture 452 toward the outlet end466, 468 of each of the terminal segments 458, 460.

Referring now to FIGS. 9 and 10 , an embodiment of a needle array device500 comprising six needles arranged in a 1×6 pattern is illustrated. Theneedle array device 500 comprises features of the 2×2 and 1×4 needlearrangement pattern illustrated in FIGS. 1-8 . The needle array device500 can include a plurality of needles 502, a removable protector, asleeve 506, a needle assembly 508, and a support base 510. Some featuresof the needle array device 500, which can be in common with the needlearray device 100 and 400, are not repeated here for clarity and brevity,but are incorporated here by reference.

The support base 510, illustrated in FIG. 10 , comprises a fluiddistribution system configured to distribute a medicament to the needleassembly 508 comprising the 1×6 needle arrangement pattern. The supportbase 510 comprises a fluid pathway for directing a medicament between aLuer connector and the plurality of needles 502.

The support base 510 can comprise an inflow aperture 552, a fluidreservoir 507, and a flow channel 554. The inflow aperture 552 and fluidreservoir 507 are positioned at an approximate center of the supportbase 510 with the flow channel 554 extending from the fluid reservoir.Some features and characteristics of the fluid distribution system thatdictate the flow of a medicament are the same as those discussedelsewhere in this application, including the fluid distribution systemsdiscussed with reference to FIGS. 1 and 7 . Accordingly, some commonfeatures and characteristics are not repeated here for clarity andbrevity, but are incorporated here by reference.

Therefore, similar to the flow channel 454 discussed above, the flowchannel 554 can comprise a shared segment 556 and a plurality ofterminal portions or segments 558, 560. The shared segment 556 extendsaway from the fluid reservoir 507 toward the respective terminalsegments 558, 560. The flow channel 554 can branch into the terminalsegments 558, 560 to divide the flow channel 554 from a single fluidpath (i.e., the shared segment 556) into two fluid paths (e.g., terminalsegments 558, 560).

Each terminal segment 558, 560 can comprise an inlet portion that is influid communication with a terminal end 566 of the shared segment 556.Further, each terminal segment 558, 560 can also comprise an outlet end568, 570 that is in fluid communication with a respective needleaperture or needle. The outlet end 568, 570 of each of the terminalsegments 558, 560 can form an end point of the flow channel 554. Theoutlet end 568, 570 of the terminal segments 558, 560 is positioned at alocation where a needle 502 is fluidly coupled with the fluiddistribution system.

In some embodiments of the present disclosure, the support base 510 cancomprise three flow channels 554, 574, 576. The three flow channels eachbranch into two additional flow channels or terminal segments (e.g.,terminal segment 558, 560) to provide a total of six flow paths. Theflow channels 574, 576 can comprise the features discussed withreference to flow channel 554, including a shared segment having aterminal end, and terminal segments having outlet ends. The features ofthe flow channels 574, 576 in common with the flow channel 554 are notrepeated here for clarity and brevity, but are incorporated here byreference.

Each of the six flow paths of the support base 510 have an end point oroutlet end (e.g., outlet ends 568, 570) at a distal end portion of theterminal segments. Each of the outlet ends can be aligned along astraight line. In some embodiments, each of the six flow paths comprisesa path length measured from the inflow aperture 552 to the outlet end ofeach flow channel.

Any of the flow channels 554, 574, 576, or a portion of a flow channel,such as the shared segment or terminal segment, can extend along atortious path. Despite the tortious path of a flow channel 554, 574,576, each flow channel 554, 574, 576 can have an approximately equalfluid path length or pathway volume between the inflow aperture 552 andthe respective flow channel outlet end, as discussed above with respectto FIG. 8 .

When a medicament is directed into the fluid distribution system throughthe inflow aperture 552, the medicament can accumulate in the sharedsegment 556 of the flow channels 554, 574, 576. As the volume ofmedicament accumulating in the flow channels 554, 574, 576 increases,some of the medicament will be directed toward the terminal segment 558,560 of the flow channels. Resistance to flow along any of the sharedsegment 556 and terminal segment 558, 560, and the accumulation ofmedicament in the flow channels 554, 574, 576, cause the medicament tomove into and evenly fill the shared segment 556 and terminal segment558, 560. With medicament evenly distributed in the flow channels 554,574, 576, additional medicament directed into the fluid distributionsystem will cause the medicament to move through the needles 502 to beejected from all needles 502 at approximately at same time, samepressure, and/or same volume.

Illustration of Subject Technology as Clauses

Various examples of aspects of the disclosure are described as numberedclauses (1, 2, 3, etc.) for convenience. These are provided as examples,and do not limit the subject technology. Identifications of the figuresand reference numbers are provided below merely as examples and forillustrative purposes, and the clauses are not limited by thoseidentifications.

Clause 1. A needle array device comprising: a needle assembly having aneedle base and a plurality of needle columns extending from the base,the needle base having upper and lower portions and a plurality ofneedle apertures extending through the needle base from a bottom surfaceof the lower portion toward a corresponding needle column, each needlecolumn supporting a needle in fluid communication with a correspondingneedle aperture; a support base having an upper portion, a Luerconnector, and an entrance aperture extending through the Luerconnector, the upper portion being couplable to the lower portion of theneedle base to form a fluid distribution cavity therebetween, the fluiddistribution cavity being in fluid communication with the entranceaperture and each of the plurality of needle apertures, the Luerconnector being couplable to a syringe device for injecting a fluid fromthe syringe device through entrance aperture and toward the needleapertures of the needle assembly; and a fluid manifold disposed in thefluid distribution cavity and having a plurality of flow channels, theflow channels operative to direct a fluid from the syringe device toeach of the needle apertures to cause the fluid to reach tips of theneedles approximately simultaneously.

Clause 2. The needle array device of Clause 1, wherein the fluidmanifold comprises a reservoir.

Clause 3. The needle array device of Clause 2, wherein the fluidmanifold comprises at least two flow channels extending from thereservoir.

Clause 4. The needle array device of Clause 3, wherein a width of thereservoir is at least twice as large as a width of the flow channels.

Clause 5. The needle array device of any one of Clauses 3 or 4, whereineach of the flow channels has a smaller cross-sectional area than thereservoir for increasing a flow resistance through the channels.

Clause 6. The needle array device of Clause 5, wherein each of the flowchannels has an approximately constant cross-sectional area.

Clause 7. The needle array device of any one of Clauses 5 or 6, whereineach of the flow channels has a decreasing cross-sectional area in adirection away from the reservoir.

Clause 8. The needle array device of any one of Clauses 3 to 6, whereineach of the flow channels has an approximately constant depth.

Clause 9. The needle array device of any one of Clauses 2 to 8, whereinthe fluid manifold comprises two flow channels extending in opposingdirections away from the reservoir.

Clause 10. The needle array device of Clause 9, wherein the two flowchannels each branch into two additional flow channels to provide atotal of four flow channels.

Clause 11. The needle array device of Clause 10, wherein the four flowchannels each have an end point, distal to the reservoir, each of theendpoints being aligned along a straight line.

Clause 12. The needle array device of any one of Clauses 10 or 11,wherein the four flow channels each have an end point and a path lengthmeasured from the inflow aperture along a longitudinal axis to the endpoint of each channel, the path lengths of each of the channels beingabout equal.

Clause 13. The needle array device of any one of Clauses 2 to 12,wherein the fluid manifold comprises four flow channels extending inopposing directions away from the reservoir.

Clause 14. The needle array device of Clause 13, wherein the four flowchannels extend in a cross-shaped pattern with the reservoir beingdisposed at a central position of the cross-shaped pattern.

Clause 15. The needle array device of any one of Clauses 13 or 14,wherein two of the four flow channels each branch into two additionalflow channels to provide a total of six flow channels.

Clause 16. The needle array device of Clause 15, wherein the six flowchannels each have an end point, distal to the reservoir, each of theendpoints being aligned along a straight line.

Clause 17. The needle array device of any one of Clauses 15 or 16,wherein the six flow channels each have an end point and a path lengthmeasured from the inflow aperture along a longitudinal axis to the endpoint of each channel, the path lengths of each of the channels beingabout equal.

Clause 18. The needle array device of any one of the preceding Clauses,wherein the fluid manifold extends from the upper portion of the supportbase into the fluid distribution cavity.

Clause 19. The needle array device of any one of the preceding Clauses,wherein the fluid manifold extends from the bottom surface of the lowerportion of the needle base into the fluid distribution cavity.

Clause 20. The needle array device of any one of the preceding Clauses,wherein the flow channels each define a pathway volume based on width,depth, and length thereof, the pathway volumes of each of the flowchannels being about equal.

Clause 21. The needle array device of any one of the preceding Clauses,wherein the needle apertures each define a cross-sectional dimensionthat is less than a cross-sectional dimension of each of the flowchannels.

Clause 22. The needle array device of any one of the preceding Clauses,wherein the arrival of fluid to the tips of the needles is simultaneouswhen an approximately constant pressure is applied to the fluid.

Clause 23. The needle array device of any one of the preceding Clauses,wherein, upon exertion of an approximately constant pressure to thefluid, the arrival of fluid to the tips of the needles is simultaneousif fluid reaches each of the needle tips within a time period of lessthan 20% of the total time for fluid to first reach the needle tips.

Clause 24. The needle array device of Clause 23, wherein the arrival offluid to the tips of the needles is simultaneous if fluid reaches eachof the needle tips within a time period of less than 10% of the totaltime for fluid to first reach the needle tips.

Clause 25. The needle array device of Clause 23, wherein the arrival offluid to the tips of the needles is simultaneous if fluid reaches eachof the needle tips within a time period of less than 5% of the totaltime for fluid to first reach the needle tips.

Clause 26. The needle array device of Clause 23, wherein the arrival offluid to the tips of the needles is simultaneous if fluid reaches eachof the needle tips within a time period of less than 2% of the totaltime for fluid to first reach the needle tips.

Clause 27. The needle array device of any one of the preceding Clauses,wherein, upon exertion of an approximately constant pressure to thefluid, an amount of fluid expelled from each of the needles is aboutequal.

Clause 28. The needle array device of any one of the preceding Clauses,wherein, upon exertion of an approximately constant pressure to thefluid, an amount of fluid expelled from each of the needles is betweenabout 5 μL and about 500 μL.

Clause 29. The needle array device of any one of the preceding Clauses,wherein, upon exertion of an approximately constant pressure to thefluid, an amount of fluid expelled from each of the needles is aboutequal.

Clause 30. The needle array device of any one of the preceding Clauses,wherein, upon exertion of an approximately constant pressure to thefluid, an amount of fluid expelled from any one of the needles is nogreater than 30% more than an amount of fluid expelled from any otherone of the needles.

Clause 31. The needle array device of any one of the preceding Clauses,wherein, upon exertion of an approximately constant pressure to thefluid, an amount of fluid expelled from any one of the needles is nogreater than 20% more than an amount of fluid expelled from any otherone of the needles.

Clause 32. The needle array device of any one of the preceding Clauses,wherein, upon exertion of an approximately constant pressure to thefluid, an amount of fluid expelled from any one of the needles is nogreater than 10% more than an amount of fluid expelled from any otherone of the needles.

Clause 33. The needle array device of any one of the preceding Clauses,further comprising a sleeve having a plurality of heads, each headdefining a height, each of the needles defining a height, wherein theheight of the heads is less than the height of the needles to define anexposed height of the needles, the exposed height of the needles beingbetween about 0.5 mm and about 5 mm to permit the needles to penetrationand fluid deposition within a subject to a depth about equal to theexposed height.

Clause 34. The needle array device of Clause 33, wherein the exposedheight is between about 1 mm and about 5 mm.

Clause 35. The needle array device of Clause 33, wherein the exposedheight is between about 2 mm and about 4 mm.

Clause 36. The needle array device of Clause 33, wherein the exposedheight is about 3 mm.

Clause 37. A needle array system comprising the needle array device ofany one of the preceding Clauses, further comprising a syringe devicecouplable to the support base.

Clause 38. The system of Clause 37, further comprising a protectorcouplable to the needle assembly for protecting the needles prior to andafter an injection procedure.

Clause 39. A needle array device comprising: a needle base having aplurality of needle apertures extending through the needle base, and aneedle in fluid communication with each needle aperture; and a fluidmanifold having an inflow aperture and a plurality of flow channels influid communication with each needle aperture; wherein a length of afluid path from the inflow aperture to each of the plurality of needleapertures is approximately equal.

Clause 40. The needle array device of Clause 39, wherein each of theplurality of flow channels comprises a pathway volume between the inflowaperture and a respective one of each of the plurality of needleapertures, and wherein the pathway volume of each of the plurality offlow channels is approximately equal.

Clause 41. The needle array device of any of Clauses 39 or 40, whereineach of the plurality of flow channels comprises a width that tapersbetween the inflow aperture and each of the plurality of needleapertures

Clause 42. The needle array device of any of Clauses 39 to 41, furthercomprising any of the features recited in Clauses 1 to 38.

Clause 43. A needle array device comprising: a needle base having aplurality of needle apertures extending through the needle base, and aneedle in fluid communication with each needle aperture; and a fluidmanifold having an inflow aperture and a plurality of flow channels influid communication with each needle aperture; wherein each of theplurality of flow channels comprises a pathway volume between the inflowaperture and a respective one of each of the plurality of needleapertures, and wherein the pathway volume of each of the plurality offlow channels is approximately equal.

Clause 44. The needle array device of Clause 43, wherein a length of afluid path from the inflow aperture to each of the plurality of needleapertures is approximately equal.

Clause 45. The needle array device of any of Clauses 43 or 44, wherein avolume of a reservoir in fluid communication between the inflow apertureand the plurality of flow channels is larger than the pathway volume ofeach of the plurality of flow channels.

Clause 46. The needle array device of any of Clauses 43 to 45, furthercomprising any of the features recited in Clauses 1 to 42.

Clause 47. A needle array device comprising: a needle base having aplurality of needle apertures extending through the needle base, and aneedle in fluid communication with each needle aperture; and a fluidmanifold having an inflow aperture and a flow channel in fluidcommunication with each needle aperture, the flow channel comprising ashared segment that splits in to two or more terminal segments.

Clause 48. The needle array device of Clauses 47, further comprising anyof the features recited in Clauses 1 to 46.

Further Considerations

In some embodiments, any of the clauses herein may depend from any oneof the independent clauses or any one of the dependent clauses. In oneaspect, any of the clauses (e.g., dependent or independent clauses) maybe combined with any other one or more clauses (e.g., dependent orindependent clauses). In one aspect, a claim may include some or all ofthe words (e.g., steps, operations, means or components) recited in aclause, a sentence, a phrase or a paragraph. In one aspect, a claim mayinclude some or all of the words recited in one or more clauses,sentences, phrases or paragraphs. In one aspect, some of the words ineach of the clauses, sentences, phrases or paragraphs may be removed. Inone aspect, additional words or elements may be added to a clause, asentence, a phrase or a paragraph. In one aspect, the subject technologymay be implemented without utilizing some of the components, elements,functions or operations described herein. In one aspect, the subjecttechnology may be implemented utilizing additional components, elements,functions or operations.

The foregoing description is provided to enable a person skilled in theart to practice the various configurations described herein. While thesubject technology has been particularly described with reference to thevarious figures and configurations, it should be understood that theseare for illustration purposes only and should not be taken as limitingthe scope of the subject technology.

There may be many other ways to implement the subject technology.Various functions and elements described herein may be partitioneddifferently from those shown without departing from the scope of thesubject technology. Various modifications to these configurations willbe readily apparent to those skilled in the art, and generic principlesdefined herein may be applied to other configurations. Thus, manychanges and modifications may be made to the subject technology, by onehaving ordinary skill in the art, without departing from the scope ofthe subject technology.

It is understood that the specific order or hierarchy of steps in theprocesses disclosed is an illustration of exemplary approaches. Basedupon design preferences, it is understood that the specific order orhierarchy of steps in the processes may be rearranged. Some of the stepsmay be performed simultaneously. The accompanying method claims presentelements of the various steps in a sample order, and are not meant to belimited to the specific order or hierarchy presented.

As used herein, the phrase “at least one of” preceding a series ofitems, with the term “and” or “or” to separate any of the items,modifies the list as a whole, rather than each member of the list (i.e.,each item). The phrase “at least one of” does not require selection ofat least one of each item listed; rather, the phrase allows a meaningthat includes at least one of any one of the items, and/or at least oneof any combination of the items, and/or at least one of each of theitems. By way of example, the phrases “at least one of A, B, and C” or“at least one of A, B, or C” each refer to only A, only B, or only C;any combination of A, B, and C; and/or at least one of each of A, B, andC.

Terms such as “top,” “bottom,” “front,” “rear” and the like as used inthis disclosure should be understood as referring to an arbitrary frameof reference, rather than to the ordinary gravitational frame ofreference. Thus, a top surface, a bottom surface, a front surface, and arear surface may extend upwardly, downwardly, diagonally, orhorizontally in a gravitational frame of reference.

Furthermore, to the extent that the term “include,” “have,” or the likeis used in the description or the claims, such term is intended to beinclusive in a manner similar to the term “comprise” as “comprise” isinterpreted when employed as a transitional word in a claim.

In one or more aspects, the terms “about,” “substantially,” and“approximately” may provide an industry-accepted tolerance for theircorresponding terms and/or relativity between items, such as from lessthan one percent to ten percent.

The word “exemplary” is used herein to mean “serving as an example,instance, or illustration.” Any embodiment described herein as“exemplary” is not necessarily to be construed as preferred oradvantageous over other embodiments.

A reference to an element in the singular is not intended to mean “oneand only one” unless specifically stated, but rather “one or more.”Pronouns in the masculine (e.g., his) include the feminine and neutergender (e.g., her and its) and vice versa. The term “some” refers to oneor more. Underlined and/or italicized headings and subheadings are usedfor convenience only, do not limit the subject technology, and are notreferred to in connection with the interpretation of the description ofthe subject technology. All structural and functional equivalents to theelements of the various configurations described throughout thisdisclosure that are known or later come to be known to those of ordinaryskill in the art are expressly incorporated herein by reference andintended to be encompassed by the subject technology. Moreover, nothingdisclosed herein is intended to be dedicated to the public regardless ofwhether such disclosure is explicitly recited in the above description.

Although the detailed description contains many specifics, these shouldnot be construed as limiting the scope of the subject technology butmerely as illustrating different examples and aspects of the subjecttechnology. It should be appreciated that the scope of the subjecttechnology includes other embodiments not discussed in detail above.Various other modifications, changes and variations may be made in thearrangement, operation and details of the method and apparatus of thesubject technology disclosed herein without departing from the scope ofthe present disclosure. Unless otherwise expressed, reference to anelement in the singular is not intended to mean “one and only one”unless explicitly stated, but rather is meant to mean “one or more.” Inaddition, it is not necessary for a device or method to address everyproblem that is solvable (or possess every advantage that is achievable)by different embodiments of the disclosure in order to be encompassedwithin the scope of the disclosure. The use herein of “can” andderivatives thereof shall be understood in the sense of “possibly” or“optionally” as opposed to an affirmative capability.

What is claimed is:
 1. A method of actuating a needle array devicecomprising causing a fluid to pass from an inflow aperture to needleapertures that are spaced apart from the inflow aperture at differentdistances, the fluid passing through a plurality of flow channels thathave approximately equal pathway lengths thereby permitting the fluid toreach tips of the needle apertures approximately simultaneously.
 2. Themethod of claim 1, wherein each of the needle apertures is in fluidcommunication with a respective needle such that the fluid reaches a tipof each needle approximately simultaneously.
 3. The method of claim 2,further comprising coupling a first sleeve to the needle array such thatthe tip of each needle is spaced apart from an outer surface of thesleeve by a first length.
 4. The method of claim 3, further comprisingcoupling a second sleeve to the needle array such that the tip of eachneedle is spaced apart from an outer surface of the sleeve by a secondlength, wherein the second length is different than the first length. 5.The method of claim 1, further comprising coupling a needle base of theneedle array device to a support base of the needle array device todefine the plurality of flow channels between the needle base and thesupport base.
 6. The method of claim 5, wherein coupling a needle baseto a support base comprising engaging a locating pin of any of theneedle base or the support base against an aperture of the other of theneedle base or the support base.
 7. The method of claim 1, furthercomprising coupling a syringe device to the needle array device suchthat the syringe device is in fluid communication with the inflowaperture.
 8. The method of claim 7, further comprising injecting a fluidfrom the syringe device to the inflow aperture.
 9. The method of claim7, further comprising withdrawing a fluid from the inflow aperture tothe syringe device.
 10. The method of claim 1, further comprisingcausing the fluid to pass through a fluid reservoir of a fluid manifoldbetween the inflow aperture and the plurality of flow channels.
 11. Amethod of actuating a needle array device comprising injecting a fluidinto a fluid manifold that diverts the fluid into a plurality of flowchannels that have approximately equal lengths and terminal endspositioned at different distances from an inflow aperture fluidlycoupled to the fluid manifold.
 12. The method of claim 11, wherein eachof the terminal ends is in fluid communication with a respective needlesuch that the fluid reaches a tip of each needle approximatelysimultaneously.
 13. The method of claim 12, further comprising couplinga first sleeve to the needle array such that the tip of each needle isspaced apart from an outer surface of the sleeve by a first length. 14.The method of claim 13, further comprising coupling a second sleeve tothe needle array such that the tip of each needle is spaced apart froman outer surface of the sleeve by a second length, wherein the secondlength is different than the first length.
 15. The method of claim 11,further comprising coupling a needle base of the needle array device toa support base of the needle array device to define the plurality offlow channels between the needle base and the support base.
 16. Themethod of claim 15, wherein coupling a needle base to a support basecomprising engaging a locating pin of any of the needle base or thesupport base against an aperture of the other of the needle base or thesupport base
 17. The method of claim 11, further comprising coupling asyringe device to the needle array device such that the syringe deviceis in fluid communication with the inflow aperture.
 18. The method ofclaim 17, further comprising injecting a fluid from the syringe deviceto the inflow aperture.
 19. The method of claim 17, further comprisingwithdrawing a fluid from the inflow aperture to the syringe device. 20.The method of claim 11, further comprising causing the fluid to passthrough a fluid reservoir of the fluid manifold between the inflowaperture and the plurality of flow channels.